FDA 510(k) Application Details - K071911

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K071911
Device Name	Computer, Diagnostic, Programmable
Applicant	INNOVISION A/S 1025 EVERETT ROAD SUITE 100 LAKE FOREST, IL 60045 US Other 510(k) Applications for this Company
Contact	RICHARD O WOOD Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/2007
Decision Date	09/07/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review